Position Overview & Specifications
Location: Stevenage
Job Summary
Based in Stevenage, the post-holder will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for commercial purposes and clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK). You will be expected to work with a team of quality professionals to provide a high-quality service to external service users.
This role is a site based role and you will be shift based, working either Sunday to Wednesday or Wednesday to Saturday (TBC). Your working hours will be 8am to 5.45pm.
Your responsibilities will include:
- Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for clinical trial and commercial purposes.
- Interact with various functions to ensure cGMP compliance in batch release related activities. Report or escalate to Line Manager any issues.
- Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use and reconciliation.
- Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues
- Preparation and checking of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance.
- Identify potential compliance risks/gaps and recommend improvements.
- Under supervision, review of premises and equipment documentation including; logbooks, protocols, reports and equipment maintenance forms.
- To liaise with internal departments regarding quality issues when required.
- Under supervision, supports in the generation of departmental metrics.
- Conduct the archiving of documentation and records within the QA team.
- Support inspection readiness activities.
- Work in adherence to local Health and Safety policies and SOPs.
- To perform other duties which are directed by the line manager/QA Team Lead.
- Any other duties as required following consultation with the post holder.
- Contribute to the continuous improvement of the Pharmaceutical Quality System (PQS).
- Contribute and facilitate in quality event investigations and in the determination of root cause.